This feasibility study will investigate whether men with metastatic prostate cancer can take part in and progress through a home-based exercise program. This study will evaluate the effects of exercise on a range of disease and treatment-related outcomes.
This 12 week multicomponent, tailored, progressive program will consist of both moderate intensity walking and strengthening exercises at home. This single centre, single arm study will incorporate a behavioural change consultation at baseline and weekly behavioural support throughout. This study will follow-up patients at 24 weeks to determine exercise maintenance. Outcome measures will be completed at baseline, 12 and 24 weeks. A qualitative evaluation will be conducted after the 24 week follow-up to determine impact, patient experience and measures that might assist in refining the program.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
Exercise programs will be individually tailored to the capabilities of each participant and gradually progressed accordingly. Each patient will be assigned a moderate intensity walking and strengthening program to complete at home. At baseline, 12 and 24 weeks patients will wear an accelerometer to determine activity levels. At these time points, patients will also complete a physical fitness assessment (timed sit-to-stand and six minute walking tests) and a range of quality of life questionnaires. At baseline, patients will receive a behaviour change consultation and continued support throughout the intervention. Each patient will receive a pedometer during the home-based, unsupervised regime to monitor step count and they are expected to complete a daily physical activity diary. Upon completion of the 24 week follow-up, patients will be invited to partake in semi-structured interviews to determine the effectiveness of the program and their experience throughout.
Northern Ireland Cancer Centre, Belfast City Hospital
Belfast, United Kingdom
Feasibility - recruitment.
The number of participants that agree to participate or are excluded.
Time frame: At baseline.
Feasibility - adherence to the exercise intervention.
Determine the percentage of patients adhering to the program and the weekly behavioral consultation sessions.
Time frame: Throughout the 24 week study period.
Feasibility - attrition rates.
The number of patients that withdraw.
Time frame: Throughout the 24 week study period.
Feasibility - safety / adverse events.
Any safety / adverse events, in general or in relation to the exercise program, will be documented by the research team.
Time frame: Monitored throughout the 24 week study period.
Feasibility - patient experience.
Determined by qualitative evaluation, using semi-structured interviews, to assess experiences, accessibility and acceptability of the exercise intervention.
Time frame: Following the study conclusion at 24 weeks.
Anthropometric assessment.
Height will be measured in cm and body weight in kg, which will be combined to report BMI in kg/m(squared).
Time frame: At baseline, 12 and 24 weeks.
Hip and waist circumference analysis.
Hip and waist circumference will be measured in cms.
Time frame: At baseline, 12 and 24 weeks.
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Functional ability assessment.
The amount of repetitions achieved during a 30 second sit-to-stand test will be recorded.
Time frame: At baseline, 12 and 24 weeks.
Physical fitness assessment.
Distance covered in meters during a six minute walk test will be recorded.
Time frame: At baseline, 12 and 24 weeks.
Objectively measure of physical activity levels.
Patients will wear an accelerometer for 7 full days.
Time frame: At baseline, 12 and 24 weeks.
Perceived physical activity levels.
Patients will complete an International Physical Activity Questionnaire (IPAQ-SF). This questionnaire will comprise 4 generic items to obtain comparable health-related physical activity. Patients will detail the number of days, hours and minutes that they undertake (1) vigorous exercise (2) moderate exercise (3) walking exercise and (4) sitting. Total physical activity will be generated and monitored for improvement or decline.
Time frame: At baseline, 12 and 24 weeks.
Cancer-related fatigue by questionnaire.
Fatigue will be measured by the Functional Assessment of Cancer Therapy - Fatigue (FACIT-Fatigue) questionnaire. Patients will score several fatigue items over the past 7 days on a scale (0 = not at all; 4 = very much), generating a total (0 - 52) with higher scores linked to greater quality of life.
Time frame: At baseline, 12 and 24 weeks.
Quality of life will be measured using a questionnaire.
Quality of life will be measured by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire. Patients will score a series of questions (0 = not at all; 4 = very much) in five sections (physical well-being; social/family well-being; emotional well-being; functional well-being; additional concerns) for the past 7 days. Higher scores will suggest better quality of life.
Time frame: At baseline, 12 and 24 weeks.
Quality of life will be measured using questionnaires.
Quality of life will be measured by the EuroQOL Five Dimension Questionnaire (EQ5D). Patients will select a level of difficulty (I have no - I have extreme) on that particular days health for mobility, self-care, usual activities, pain / discomfort and anxiety / depression. Patients will then rate 'how good' or 'how bad' their health is on that day using a 100 point scale (0 = worst health you can imagine; 100 = best health you can imagine).
Time frame: At baseline, 12 and 24 weeks.
Pain will be measured through a questionnaire.
Bone pain will be monitored using the Brief Pain Inventory Short Form (BPI-SF).
Time frame: At baseline, 12 and 24 weeks.